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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Decision Date To: 05/15/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
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WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION DEN100025 K101699 03/31/2011
DENV DETECT IGM CAPTURE ELISA INBIOS INTL., INC. DEN100020 K100534 04/08/2011
APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED DEN110012 K102911 04/19/2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMER TEARSCIENCE, INC. DEN100017 K093937 06/28/2011
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR APTUS ENDOSYSTEMS, INC. DEN100026 K102333 11/21/2011
INFRASCANNER, MODEL 1000 INFRASCAN, INC. DEN100002 K080377 12/13/2011
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL VIOGUARD DEN100013 K092996 12/20/2011
STRATIFY JCV(TM) ANTIBODY FOCUS DIAGNOSTICS, INC. DEN120008 K112394 01/20/2012
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE C PHADIA US INC. DEN120001 K103039 02/15/2012
SYSTEM 1E PROCESS BIOLOGICAL MONITORING STERIS Corporation DEN110002 K100049 03/30/2012
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